Objectives Specimen Rejection

Transcription

1 Objectives Specimen Rejection Why Does This Sample Need Recollected? Beth Warning, MS, MLS cm University of Cincinnati MLS Program Discuss common preanalytical causes for rejection of blood and non-blood samples Identify patient factors that may lead to specimen rejection and recollection Discuss how the patient may be affected when testing is delayed or rejected When Are Specimen s Rejected? Mean rejection rate of 1% or less of heme and chem specimens * Higher rejection for Inpatient and ED Majority are preventable 6% result in inappropriate treatment outcomes Something s Not Right Who identifies the error? Are rejections tracked as part of CQI? Where does the specimen originate from? Who performed the collection? Which tests are mainly affected? *2014 CAP QProbe Something s Not Right Examine the sample visually Labeling Tube type Appearance Review how the sample was collected Something s Not Right Is the specimen acceptable with respect to the test ordered based on the transport conditions Temperature of sample upon receipt Length of time between sample collection and receipt 1

2 What pre-analytical factors affect specimen rejection? Labeling Errors Requisition mismatch Missing identification information/incomplete labeling Missing label/unlabeled Mislabeled WBIT wrong blood in tube Preventable with training! Improper Collection Wrong collection container Sterile vs non sterile Tube/anticoagulant/order of draw Improper ratio of anticoagulant to sample Short draw or overfill Wrong specimen type Plasma vs serum Preventable with training! Insufficient Volume QNS to perform the necessary testing Pediatric, neonatal and elderly collections Multiple tests per tube Blood cultures Preventable with proper training! Clotted Samples EDTA most susceptible due to inadequate or delayed mixing of the sample after draw Microtubes and the pediatric patient Preventable with proper training! Timing of Collection Therapeutic drug monitoring Peak/Trough collections Cardiac troponin values Blood cultures Biorhythms Cortisol Preventable with proper training! 2

3 Handling Error Delay in centrifugation Glucose, potassium Delay in delivery of microbiology samples Overgrowth of normal flora Protected from light Bilirubin Handling Error Frozen vs not frozen Serum or plasma vs whole blood Delivered on ice/subjected to heat Ammonia, lactate, renin Microbiology specimens Preventable through following established protocol Hemolysis Cell membrane of erythrocyte ruptures Hb and cellular components released Visible when free plasma Hb is >3mg% Preanalytical Causes of Hemolysis Collection method Needle gauge Collection method Specimen transfer device Vigorous shaking Pre Analytical Causes of Hemolysis Collecting personnel Centrifugation Pneumatic tube jarring Preventable through following established protocol! Affects of Hemolysis Spectral interference in test methodology Release of intracellular material to cause a false increase in analytes Enzyme release to interfere with methodology Dilutional effect 3

4 Affects of Hemolysis Increase in analyte value K+, LD, TP, Alb, Ca 2+, Mg 2+, ALP, CK, AST, Phos Decreased values with hemolysis TNI, Haptoglobin, Bilirubin, Varied results Hb, RBC, MCHC, Plt Other Causes for Rejection Broken tubes Needles still attached to syringes No requisition Missing information such as physician name, phone, diagnosis What About Rejecting Non-Blood Samples? Anaerobic Cultures Collected inappropriately Inappropriate site of collection NP, Sputum, Urine, Stool, Vaginal/Cervical Time delay Decreases viability of organism Urine Samples Incorrect collection container Leaking container QNS Inappropriate storage Store at RT 48 hrs for stabilized CCM Store at RT 24 hrs for stabilized culture tubes Urine Samples Incorrect collection time First morning collection Improper collection 24 hour collection Incorrect preservation Non-sterile 4

5 Urine for Drug Screening Failure to follow protocol regarding COC and documentation of collection Insufficient volume Adulterated sample Overall appearance Sample temperature within 4 minutes of collection ph between Specific gravity <1.002 or >1.020 Creatinine >20mg/dL Respiratory Cultures Timing of collection Prior to the start of antibiotics Inappropriate swab Inappropriate collection Normal flora contamination on collection Timing of testing Delay in processing, expired media Sputum Inadequate sample May not be representative of the lower respiratory tract = oropharyngeal contamination Contamination of the container by the patient >10 SEC per low power field <25 WBC per low power field >10 SEC and <25 WBC per low poser field Delay in transport or testing Inappropriate storage Stool Inappropriate specimen Solid stool vs liquid stool Inadequate volume Presence of urine Presence of barium, antacids, antibiotics Storage or transport issues Leaking containers Overgrowth of normal flora Drying of sample Extremes in temperature Patient Factors Affecting Recollection But It s Not My Fault Patient non compliance Fasting Adhering to collection instructions 5

6 In-vivo Hemolysis Transfusion reactions ABO incompatibility, delayed reactions Hemorrhagic conditions DIC, SS, HUS, TTP AIHA Lipemia Caused by increased concentration of triglycerides Seen as cloudiness or turbidity, milky discoloration of serum or plasma Causes analytical interference Spectral Immunometric Potentiometric Lipemia Can be prevented by patient fasting or delayed sampling based on timing of the meal May be corrected by ultracentrifugation Icteric Samples High levels of bilirubin in excess of 1.5 mg/dl Patients have conditions which cause increased bilirubin such as biliary obstruction or viral hepatitis Can cause spectral interference with some analyte measurements Cholesterol, triglyceride, lipase, total protein, GGT So, How Often Are Specimens Rejected? 453,171 samples, with 27,067 rejected Inpatient 28% ED 41% Pediatric 10% Adult 31% Biochemia Medica

7 2.5% chemistry tests 3.2% CBCs 9.8% ABGs 13.3% Coagulation samples 12.8% TDM 3.5% Cardiac markers 12% Hormone tests Biochemia Medica 2015 Stat lab rejections 46.4% Chemistry hemolyzed 43.2% Hematology clotted 6.4% Lost samples 2.9% Inadequate sample to coag ratio 0.7% Pt ID 0.3% Wrong tubes 0.1% Missing requisitions Biochemia Medica 2015 Chemistry rejections 28% fibrin clots 9% QNS Coag, ABG, CBC Clotted 35% QNS 13% CAP Q Probe (2014) study of 78 facilities Over 2 million samples 4794 rejections 92% due to inappropriate/inadequate sample 8% improper labeling 88% were recollected 11% were not recollected (abandoned) Biochemia Medica 2015 Non-blood Six month study, 2000 samples Reviewed sputum, urine, stool, body fluids and blood cultures 5.3% microbiology samples were rejected 8% body fluids 6.8% urine 5.3% stool 3.3% sputum Effects on Patient Care Inconvenience to the patient Iatrogenic blood loss Questionable quality of results Delay in diagnosis Delay in treatment Leads to new sample request Cancellation of current request Adverse patient outcomes Journal of Dental and Medical Sciences

8 To Reject or Accept? All specimens must meet the requirements before being accepted for testing CLSI C56-A Hemolysis, Icterus, and Lipemia/Turbidity Indices as Indicator of Interference in Clinical Laboratory Analysis Provide a quantitative estimation of the degree of hemolysis, lipemia, and icterus based on the manufacturer recommendations Provide a visual assessment using a color chart In Summary Clearly define rejection criteria in the workplace Identify under what circumstances new specimens will be collected Define when a new sample is to be requested Identify what is not acceptable Institute quality indicators/performance indicators for Misidentification, specimen collection, transport issues Monitor error rate and types Perform root cause analysis to identify cause of error In Summary Education, training and competency must be provided Educate staff on best practices in sample collection Badrick, Tony et al. Consensus Statement for the Management and Reporting of Haemolysed Specimens. The Clinical Biochemist Reviews 37.4 (2016): Bolton-Maggs, P. H. B., Wood, E. M. and Wiersum-Osselton, J. C. (2015), Wrong blood in tube potential for serious outcomes: can it be prevented?. Br J Haematol, 168: doi: /bjh Carraro, Paola, Servidio, Giuseppe, Plebani, Mario. (2007). Errors in a stat laboratory: Types and frequencies 10 years later. Clinical Chemistry, 53, doi: /clinchem Castellone, Donna. Advance Healthcare Network Interference of hemolysis, icteric, and lipemia coagulation testing. October 4, 2011) Dikmen, Zeliha Gunnur, Asli Pinar, and Filiz Akbiyik. Specimen Rejection in Laboratory Medicine: Necessary for Patient Safety? Biochemia Medica 25.3 (2015): PMC. Web. Donald S. Dimeski, Goce. Interference Testing. The Clinical Biochemist Reviews29.Suppl 1 (2008): S43 S48. Guimares, Alexandre, Wolfart, Marilei, Brisolara, Maria, Dani, Caroline.Clinical Biochemistry 45(2012) Causes of rejection of blood samples handled in the clinical laboratory of a university Hospital in Porto Alegre Kurec, Anthony. Recollecting blood specimens. MLO January 23, 2017 Karcher and Christopher M. Lehman (2014) Clinical Consequences of Specimen Rejection: A College of American Pathologists Q-Probes Analysis of 78 Clinical Laboratories. Archives of Pathology & Laboratory Medicine: August 2014, Vol. 138, No. 8, pp Nikolac, Nora. Lipemia: Causes, Interference Mechanisms, Detection and Management. Biochemia Medica 24.1 (2014): PMC. Paolo Carro, Mario Plebani, M. Vernoski, Barbara K., "Effect of Blood Collection Practices on Emergency Department Blood Specimen Rejection Rates" (2013). Wiersum-Osselton, J. C. (2015), Wrong blood in tube potential for serious outcomes: can it be prevented?. Br J Haematol, 168: doi: /bjh